Assessment of Neurofilaments Levels in Premature Newborns: Study of Their Early Development

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 3
SponsorCentre Hospitalier Universitaire de Liege

About this trial

This is a prospective observational study aiming to establish reference values of neurofilaments in late preterm newborns (34-37 weeks of gestation) and to evaluate their early postnatal evolution.

Neurofilaments are neuronal proteins released into the blood when nerve cells are damaged. They have emerged as promising biomarkers in neurodegenerative diseases, particularly in spinal muscular atrophy (SMA), where higher levels are associated with disease activity. However, very limited data exist on the normal dynamics of neurofilament levels in preterm infants.

In this study, up to 15 preterm newborns hospitalized in the neonatal unit will be enrolled (5 at 34 weeks, 5 at 35 weeks, 5 at 36 weeks of gestation). A maximum of 1 mL of additional blood will be collected only during routine clinically indicated blood draws, at birth, on day 2, and weekly until 37 weeks of gestation. Samples will be analyzed for neurofilament concentrations and compared across gestational ages, over time, and with existing data from term newborns and SMA patients.

The expected outcome is to generate normative data on neurofilament levels in late preterm infants, which will help interpret biomarker values in future studies and optimize early diagnosis and treatment strategies for neurodegenerative diseases such as SMA.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Gestational age between 34 and 37 weeks of amenorrhea.

Blood test scheduled for clinical reasons.

Signed parental consent.

Disqualifiers

Known neurological disorders.

Severe congenital malformations.

Medical contraindication to blood sampling.

Trial population

Late preterm infants (34-37 weeks of gestation) admitted to the neonatal unit

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood sampling for neurofilament analysis

    Other intervention

    An additional blood sample (maximum 1 mL) is collected during routine clinically indicated blood draws in late preterm infants (34-37 weeks of gestation). Samples are obtained at birth, day 2, and weekly until 37 weeks of gestation if blood draws are already planned. No separate venipuncture is performed. Samples are processed and stored for subsequent neurofilament concentration analysis.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Neurofilament sampling in late preterm newborns1 intervention

Trial outcomes

Primary outcomes

1

Neurofilament concentration in blood of late preterm infants

Measurement of blood neurofilament light chain (NfL) concentrations to establish reference values and describe their early postnatal evolution in late preterm infants.

Time frame
From birth to 37 weeks of gestational age (up to 3 weeks after inclusion depending on gestational age at birth).

Secondary outcomes

1

Postnatal evolution of neurofilament concentrations

Analysis of changes in neurofilament levels over time in late preterm infants, from birth to 37 weeks of gestational age.

Time frame
From birth up to 37 weeks of gestational age (longitudinal follow-up).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Liege

Lead sponsor

Centre Hospitalier Régional de la Citadelle

Collaborator